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Central Pain Syndrome in Survivors of Head and Neck Cancer

Primary Purpose

Head and Neck Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IPC-1000
Magnetic resonance imaging
Correlative Studies
Sponsored by
Vanderbilt-Ingram Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Head and Neck Cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with histologically proven head and neck cancer

  • Patients without a diagnosis of head and neck cancer (up to 10 patients, see below)

    • We anticipate enrolling a total of 75 patients with a history of head and neck cancer who will complete all questionnaires and MRI scanning. We will also recruit up to 10 patients WITHOUT a diagnosis of head and neck cancer to facilitate optimization of the MRI scanning processes. This will allow us to address logistical issues, such as pressure stimulator setup and timing of each scan to be performed.
  • Completed multi-modality therapy a minimum of 6 weeks prior to study entry.
  • Willing and able to provide informed consent
  • All participants must be at least 21 years of age
  • Able to speak English

Exclusion Criteria:

  • Patients who are pregnant
  • Patients who are unable to lie still
  • Patients who are unable tolerate pressure stimulator
  • Non-MRI compatible devices such as aneurysm clips, cardiac pacemakers or defibrillators, cochlear implants, hardware, or any other implants
  • Iron-based tattoos, pieces of metal (bullet, BB, shrapnel) close to or in an important organ (such as the eye), or other non-MRI compatible metal in the body

Sites / Locations

  • Vanderbilt-Ingram Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Response to Pain

Arm Description

Brain's response to pain using magnetic resonance imaging (MRI)

Outcomes

Primary Outcome Measures

Magnetic Resonance Imaging (MRI) to Correlate With One of Three Pain Phenotypes 1) no Pain, 2) Central Pain, 3) Nociceptive Pain
MRI scan of brain to measure response to stimulated pressure to thumbnail
Magnetic Resonance Imaging (MRI) to Correlate Presence of Chronic Systemic Symptoms With Pain Phenotype
MRI scan of brain to measure response to stimulated pressure to thumbnail

Secondary Outcome Measures

Full Information

First Posted
October 14, 2019
Last Updated
August 23, 2022
Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04128267
Brief Title
Central Pain Syndrome in Survivors of Head and Neck Cancer
Official Title
Characterization of Central Pain Syndrome in Survivors of Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Recruitment/accrual impacted by COVID and technical issues with equipment
Study Start Date
November 4, 2019 (Actual)
Primary Completion Date
July 21, 2022 (Actual)
Study Completion Date
July 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a cross-sectional pilot study of head and neck cancer survivors who have completed multi-modal treatment to assess and characterize the presence of distinct pain syndromes.
Detailed Description
Primary objectives: To correlate structural and functional MRI signature with one of three pain phenotypes in head and neck cancer survivors: 1) no pain, 2) central pain, and 3) nociceptive pain. To correlate the presence of chronic systemic symptoms with pain phenotype Exploratory objectives: - DNA, RNA, and plasma will be collected for genomic, transcriptomic, and proteomic studies. Results will be vertically integrated along with the results of clinical studies described within this protocol to identify targets for future correlative studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Response to Pain
Arm Type
Experimental
Arm Description
Brain's response to pain using magnetic resonance imaging (MRI)
Intervention Type
Device
Intervention Name(s)
IPC-1000
Intervention Description
Delivers pressure to thumbnail for five seconds at a time
Intervention Type
Device
Intervention Name(s)
Magnetic resonance imaging
Intervention Description
Scan of brain using Magnetic resonance imaging
Intervention Type
Other
Intervention Name(s)
Correlative Studies
Intervention Description
Administration of questionnaires via computer
Primary Outcome Measure Information:
Title
Magnetic Resonance Imaging (MRI) to Correlate With One of Three Pain Phenotypes 1) no Pain, 2) Central Pain, 3) Nociceptive Pain
Description
MRI scan of brain to measure response to stimulated pressure to thumbnail
Time Frame
Approximately 8 weeks
Title
Magnetic Resonance Imaging (MRI) to Correlate Presence of Chronic Systemic Symptoms With Pain Phenotype
Description
MRI scan of brain to measure response to stimulated pressure to thumbnail
Time Frame
Approximately 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with histologically proven head and neck cancer Patients without a diagnosis of head and neck cancer (up to 10 patients, see below) We anticipate enrolling a total of 75 patients with a history of head and neck cancer who will complete all questionnaires and MRI scanning. We will also recruit up to 10 patients WITHOUT a diagnosis of head and neck cancer to facilitate optimization of the MRI scanning processes. This will allow us to address logistical issues, such as pressure stimulator setup and timing of each scan to be performed. Completed multi-modality therapy a minimum of 6 weeks prior to study entry. Willing and able to provide informed consent All participants must be at least 21 years of age Able to speak English Exclusion Criteria: Patients who are pregnant Patients who are unable to lie still Patients who are unable tolerate pressure stimulator Non-MRI compatible devices such as aneurysm clips, cardiac pacemakers or defibrillators, cochlear implants, hardware, or any other implants Iron-based tattoos, pieces of metal (bullet, BB, shrapnel) close to or in an important organ (such as the eye), or other non-MRI compatible metal in the body
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dianne Lou, MD, PhD
Organizational Affiliation
Vanderbilt Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Central Pain Syndrome in Survivors of Head and Neck Cancer

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